Treatment Initiation of Venetoclax in Combination with Azacitidine or Decitabine in an Outpatient Setting in Patients with Untreated Acute Myeloid Leukemia

Background: Venetoclax (Ven), a highly selective BCL-2 inhibitor, combined with azacitidine (Aza) suppresses oxidative phosphorylation, which selectively targets leukemia stem cells that drive initiation and perpetuation of acute myeloid leukemia (AML; Pollyea. Nat Med. 2018;24:1859), an aggressive malignancy most common in older adults. Safety and efficacy of Ven combined with the hypomethylating agents (HMA) Aza or decitabine (Dec) for the treatment of newly diagnosed AML in patients (pts) who are ineligible to receive intensive chemotherapy has been demonstrated (DiNardo. Blood. 2019;133:7; DiNardo. N Engl J Med. 2020;383:617). Phase 1 and Phase 3 studies initiated Ven + HMA in an inpatient setting due to the nature of the study design and concerns of tumor lysis syndrome (TLS) based on chronic lymphocytic leukemia treatment with Ven. Safety and efficacy of Ven + HMA treatment initiation in an exclusively outpatient setting is being evaluated in an ongoing Phase 3b, single-arm, multicenter, open-label study (NCT03941964). Here, we present pt baseline (BL) characteristics and safety during initial outpatient dose ramp-up of Ven + HMA.